One in three men will experience moderate-to-severe lower urinary tract symptoms in their lifetime, with symptoms including frequent urination, difficulty starting urination, nocturia and a weak urine stream. Although these are common symptoms, in older men, they can significantly impact quality of life.

The majority of male urinary symptoms are attributed to an enlarged prostate (benign prostatic hyperplasia or BPH), which is a non-cancerous growth of the prostate that occurs as most men age and can obstruct the flow of urine. BPH is commonly treated with medications that attempt to relieve that obstruction by shrinking the prostate or relaxing the prostatic smooth muscle, such as Tamsulosin, an Alpha-1 adrenergic receptor antagonist (a1-blocker).

While Tamsulosin can be used to successfully treat urinary symptoms in many patients, for some, the uncertain or modest benefits can be outweighed by the harms, which include sudden drops in blood pressure, dizziness, falls, fractures, and medication burden. Still, 1 in 5 older men with BPH receive Tamsulosin and often continue treatment with the medication after their symptoms have resolved due to a fear of recurrence.

To assess the individualized benefits and harms of Tamsulosin therapy, UCSF researchers conducted a proof-of-concept, randomized clinical trial comparing continuation of long-term Tamsulosin treatment with a matching placebo among older men with BPH. Their study found that approximately 1 in 3 participants receiving Tamsulosin therapy for BPH had minimal or no effect from the Tamsulosin therapy versus a placebo on urinary symptoms. 

Their study¹ appeared in JAMA Network Open on July 6, 2026.

“Our findings suggest that long-term tamsulosin therapy should be periodically reassessed because the balance between benefit and harm may change over time.” said study first author Scott R. Bauer, MD, ScM, UCSF associate professor of Medicine, Urology, Epidemiology and Biostatistics.

Their unique clinical trial design was a randomized, double-blind, placebo-controlled, multiple crossover trial (N-of-1) with each participant receiving both Tamsulosin and placebo. Each participant served as their own control, allowing researchers to compare urinary symptoms during two-week treatment periods randomly alternating between Tamsulosin and placebo.

Among the 31 participants who attempted the N-of-1 protocol, 36.7% had minimal or no effect from the Tamsulosin and another 36.7% had only a moderate effect. While 13.3% had strong effect from Tamsulosin, and another 13.3% did not tolerate the one-week placebo due to worsening symptoms, the study results suggest that a substantial number of patients may be candidates for Tamsulosin deprescribing.

“We found that tamsulosin treatment response varied substantially from person to person and that an N-of-1 deprescribing trial can precisely measure how much benefit an individual is receiving from continued treatment,” said Bauer. “The results of this small clinical trial suggest that we should reconsider the assumption that long-standing BPH medications should automatically be continued. For many older men, especially those taking several medications, periodically reassessing whether tamsulosin is still providing meaningful benefit is an important part of age-friendly, personalized BPH care.”

The researchers acknowledge the small size of this proof-of-concept study and believe larger studies are needed to confirm generalizability across clinical settings and patient populations, to identify predictors of Tamsulosin response, and to test the effect of N-of-1-guided deprescribing on clinical outcomes. 

Reference:

1) https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2851139?guestAccessKey=85cf6b00-1db6-41df-a8a8-dec03be77c1d&utm_source=for_the_media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=070626

(Newswise/HG)